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Clinical Trials/NCT00393614
NCT00393614
Unknown
Phase 4

Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA) - a Placebo Controlled Double-blind Cross-over-study

Oslo University Hospital1 site in 1 country30 target enrollmentStarted: May 2007Last updated:

Overview

Phase
Phase 4
Sponsor
Oslo University Hospital
Enrollment
30
Locations
1
Primary Endpoint
24 hour EEG

Overview

Brief Summary

In clinical practice at the National centre for epilepsy (SSE) in Norway we see many children who have subclinical epileptiform activity in EEG that increases substantially during slow wave sleep (SSEA; subclinical sleep-activated epileptiform activity). They may or may not have seizures. Hence, according to the definition some children with SSEA do not suffer from epilepsy because they do not experience seizures. Many of these children have symptoms such as: attention deficit hyperactivity disorders (AD/HD), dyslectic problems, sleep problems, tantrums or autistic symptoms . We hypothesize that this subclinical epileptiform activity during slow sleep may act negatively on cognitive functions, language and behaviour in some children; even when the spike-wave discharges are less frequent than in CSWS (continuous spike-waves during slow sleep).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Care Provider, Investigator)

Eligibility Criteria

Ages
5 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Children 5-10 years

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

24 hour EEG

Time Frame: End of the study

Secondary Outcomes

  • Health related quality of life(End of the study)
  • Neuro-psychological testing,(End of the study)
  • Behavioral problems(End of the study)

Investigators

Sponsor
Oslo University Hospital
Sponsor Class
Other

Study Sites (1)

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